Use of Cardiac-MRI to Predict Results for People With Severe Aortic Stenosis

NCT01905852 | Withdrawn

• 2 other identifiers: 13016813-H-0168
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: \- Aortic valve stenosis is a disease that makes a major heart valve get smaller. This reduces heart function and causes death. Severe aortic stenosis (AS) can be treated in a couple of ways, including replacing a heart valve. Objectives: Researchers want to study fibrosis in the heart. A sub-study will test whether heart function and blood supply improve after a valve replacement. Eligibility: \- Adults at least 18 years old with aortic stenosis. Design:

• Participants will visit a clinic for 1 day for magnetic resonance imaging (MRI) of their heart. This uses magnets, radio waves, and computers to produce detailed pictures of the heart.
• After this visit, participants will have their aortic valve procedure at the the Washington Hospital Center. A hospital team will contact participants for 1 year by phone or email. This follow-up will consist of 15 minutes of questions about the participant s health status.
• Some participants will join a sub-study.
• They will be given an additional medication to evaluate the blood supply of the heart.
• They will visit a clinic for 1 day for an MRI of their heart, as part of the main study, prior to the aortic valve replacement.
• After they have their valve replaced at the hospital, they will return to the clinic for another MRI.
• They will have the same follow-up as in the main study.

Conditions

Aortic Valve Stenosis

Keywords

Transcatheter Aortic Valve Replacement; Ejection Fraction; Fractional Flow Reserve; Myocardial Fibrosis

Outcome Measures

Primary Outcomes (1)

• To assess the ability of cardiac MRI measurement of extracellular volume fraction (related to myocardial fibrosis) to predict short and long term LV function of subjects with severe aortic stenosis undergoing transcatheter AVR.

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe aortic stenosis defined as aortic valve area of less than 1 cm(2) or index area of 0.6 cm(2)/m(2) by echocardiography.
• Symptomatic patients with aortic stenosis referred for medically indicated AVR
• LV EF less than or equal to 0.50
• Signed informed consent to participate in the study.
• Specific criteria for MR perfusion sub-study:
• Absence of any significant coronary lesions or presence of coronary disease for conservative (medical) therapy\<TAB\>.

You may not qualify if:

• Inability to sign written informed consent.
• Subjects with contraindication to MRI scanning, including the following devices or conditions:
• Cardiac pacemaker or implantable defibrillator
• Cerebral aneurysm clip
• Neural stimulator (e.g. TENS-Unit)
• Any type of ear implant
• Ocular foreign body (e.g. metal shavings)
• Any implanted device (e.g. insulin pump, drug infusion device)
• Metal shrapnel or bullet.
• Atrial fibrillation
• Subjects with a known hypersensitivity, allergy or contraindication to iodine or gadolinium
• Impaired renal excretory function, calculated as Glomerular Filtration Rate (GFR) \<30mL/min/1.73m(2).
• Contraindications for intravenous adenosine infusion:
• Known hypersensitivity to adenosine
• Known or suspected significant bronchoconstrictive or bronchospastic disease

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead
• Medstar Health Research Institute: collaborator

Related Publications (3)

• Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 May 3;366(18):1686-95. doi: 10.1056/NEJMoa1200384. Epub 2012 Mar 26.

  PMID: 22443479 BACKGROUND

• Makkar RR, Fontana GP, Jilaihawi H, Kapadia S, Pichard AD, Douglas PS, Thourani VH, Babaliaros VC, Webb JG, Herrmann HC, Bavaria JE, Kodali S, Brown DL, Bowers B, Dewey TM, Svensson LG, Tuzcu M, Moses JW, Williams MR, Siegel RJ, Akin JJ, Anderson WN, Pocock S, Smith CR, Leon MB; PARTNER Trial Investigators. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012 May 3;366(18):1696-704. doi: 10.1056/NEJMoa1202277. Epub 2012 Mar 26.

  PMID: 22443478 BACKGROUND

• Fraccaro C, Al-Lamee R, Tarantini G, Maisano F, Napodano M, Montorfano M, Frigo AC, Iliceto S, Gerosa G, Isabella G, Colombo A. Transcatheter aortic valve implantation in patients with severe left ventricular dysfunction: immediate and mid-term results, a multicenter study. Circ Cardiovasc Interv. 2012 Apr;5(2):253-60. doi: 10.1161/CIRCINTERVENTIONS.111.964213. Epub 2012 Apr 10.

  PMID: 22496081 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Andrew E Arai, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 23, 2013
• Study Start: June 27, 2013
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: September 13, 2019

Record last verified: 2014-04-08